AvantGen receives an award from the NIH/RADx to commercialize its anti-SARS-CoV-2 nucleocapsid antibodies for ultra-high sensitivity lateral flow assay development

AvantGen receives an award from the NIH/RADx to commercialize its anti-SARS-CoV-2 nucleocapsid antibodies for ultra-high sensitivity lateral flow assay development

SAN DIEGO, May 25, 2021 (GLOBE NEWSWIRE) — AvantGen, a San Diego-based biotech, is a leader in the use of yeast display technology for human and rabbit monoclonal antibody discovery and optimization. AvantGen has received an award from the NIH’s RADx Next program to expedite the commercialization of its high affinity rabbit monoclonal antibodies against the nucleocapsid (N) protein of SARS-CoV-2.  A pair of the antibody clones has been evaluated extensively in a rapid lateral flow assay (LFA) format for the detection of SARS-CoV-2 N protein. The results demonstrated the test is highly sensitive and superior to many current marketed antigen tests.

Key features of the pair of antibody clones are:

  1. Both clones exhibit pM affinity and recognize the N protein variants from commonly circulating SARS-CoV-2 variants, including UK (D3L, S235F), S. African (T205I), and Brazilian (P80R) variants with similar affinity to the original strain.
  2. A prototype LFA test developed using the two clones exhibits an LOD in the range of 30 to 50 TCID50/mL with both live SARS-CoV-2 virus (Washington state SARS-CoV-2 isolate WA1-F6/2020) and gamma-irradiated SARS-CoV-2. Data were independently confirmed by an NIH sponsored laboratory.
  3. The LFA test can detect N protein in clinical samples (n=55; Ct values 14-38) with 100% sensitivity. The data were generated internally and confirmed by an NIH sponsored laboratory.
  4. The LFA test is specific for SARS-CoV-2 and does not cross-react with other circulating coronaviruses.

“Simple antigen tests offer the advantages of ease of use, low cost and stability for non-laboratory settings.  However, they often lack the necessary sensitivity and specificity which translates to unacceptable rates of false positive and false negative results, limiting their use in the pandemic’, said Xiaomin Fan, Ph.D., Founder and President of AvantGen, “We are extremely pleased to see that our rapid test exhibits an ultra-high sensitivity similar to that of the CDC’s PCR test. With the funding from RADx, we look forward to the further development of rapid antigen tests with these antibodies”.

For more information, please contact Catherine Woods at cmwoods@avantgen.com.

About AvantGen

AvantGen, Inc is a leader in the use of yeast display technology for antibody discovery and optimization. Founded by experts in the creation of antibody discovery and optimization platforms, AvantGen excels in the rapid generation of antibodies for therapeutic, diagnostic and research tool applications. The Company’s platforms include a robust yeast display system, large natural human antibody database, fully human antibody libraries comprised of over 100 billion antibody clones displayed by yeast cells, NK and T cell engager technology, as well as novel methodologies for rabbit monoclonal antibody generation. These versatile platforms can be used to discover and optimize antibodies directed at specific disease targets, affinity mature existing antibodies to

improve their binding properties and humanize antibodies to render non-human antibodies suitable for human therapeutic applications, as well as generate rabbit monoclonal antibodies for applications that need extremely high specificity, such as antibodies capable of distinguishing point mutations and post-translational modifications for IHC, and anti-idiotype antibodies for PK studies. AvantGen’s partners include pharmaceutical, biotech, diagnostic and government entities, many of which are repeat customers. For more information, visit www.avantgen.com.

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faq Want to learn more?

  • Why Yeast?

    Yeast, or Saccharomyces cerevisiae aka brewer’s yeast to be exact, has the best of both worlds as a model organism for drug discovery. In selecting the right model, two opposing factors are: 1) finding an organism that can be used cost-effectively and ethically, and 2) being physiologically relevant by having it as similar as humans, the intended patients. This is where yeast has all the advantages: 1) it is unicellular, grows incredibly fast at a doubling rate of 90 minutes, and is easy and safe (non-pathogenic) to culture, meanwhile 2) as a eukaryote it can properly express, fold, and glycosylate proteins such as antibodies similar to mammals.

  • Yeast is “similar” but not the same as in humans with regards to post-translation modification (PTM) of proteins such as glycosylation?

    Correct, there are slight differences in the PTM profiles of proteins expressed in yeast versus mammals. However, we recombinantly express our lead antibodies in HEK293 or CHO cells and rarely observe a loss in activity. This is in stark contrast with E. coli-based systems like phage or cell-free, where bacteria lack protein glycosylation machinery.

  • Is affinity maturation required after using one of your platforms?

    Due to our large size rationally-designed Germliner™ library collection coupled with our rapid cell sorting based screening, we consistently obtain single-digit and subnM affinity antibodies with optimal developable characteristics. Interestingly, our popular AvantGeneer affinity maturation platform has been frequently used to optimize client antibodies that were originally discovered with hybridoma and human transgenic mouse platforms.

  • My target is a GPCR. Will your platform work?

    We have had success with multi-transmembrane proteins such as GPCRs, by using virus-like-particles (VLPs), nanodiscs, and client-designed variants with increased solubility.

  • What materials should I provide?

    We typically use various amounts of biotinylated, DyLight™ 650 conjugated, and unlabeled antigens for all projects. It’s important that both labeled and unlabeled antigens are QC’ed by provider, third party, and/or AvantGen. >0.5 mg/mL concentration, >80% monomer percentage, and >90% purity. Preferred buffer is PBS and no tris-based buffers please.

    Estimated Material Amounts*

    Application Stage Discovery Affinity Maturation Rabbit mAb
    All stages 1.5-2 mg biotinylated or 2-3 mg unlabeled 0.5 mg biotinylated or 1 mg unlabeled 2 mg unlabeled and 1 mg biotinylated
    FACS and screening 0.5-1 mg biotinylated or 1-2 mg unlabeled 0.2-0.5 mg biotinylated or 0.5-1 mg unlabeled 1 mg biotinylated and 0.2 mg unlabeled
    Screening only 0.2 mg biotinylated or 0.2-0.5 mg unlabeled 0.2 mg biotinylated or 0.2-0.5 mg unlabeled 0.2-0.5 mg unlabeled

    *Assuming 50 kDa antigen. AvantGen can bioconjugate and QC as needed.

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